Portland, Oregon 97210


Purpose:

Gastrointestinal leaks or perforations are currently treated through either open or laparoscopic surgical procedures. The purpose of this research is to determine whether new endoscopic tools are safe and effective in the treatment of such conditions and can overcome the need of invasive surgical procedures.


Study summary:

Novel endoscopic devices have the potential to overcome the need for invasive surgery for the treatment of gastrointestinal fistulas or perforations. Instead of a large abdominal incision or multiple incisions with the related postoperative morbidity endoscopic techniques will be used used which require no postoperative limitation of activities. Using novel tissue closure devices, such as a Tissue Apposition System or an endoscopic suturing system, we will evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in patients having either chronic gastrointestinal fistulas or acute perforations.


Criteria:

Inclusion Criteria: - Gastrointestinal fistula and perforation - Ability to undergo general anesthesia - Ability to give informed consent Exclusion Criteria: - Contraindicated for esophagogastroduodenoscopy (EGD) - Contraindicated for colonoscopy - BMI ≥ 40 - Presence of esophageal stricture - Altered gastric anatomy - Intraabdominal abscess or severe inflammation


NCT ID:

NCT01303653


Primary Contact:

Lee L Swanstrom, MD
Phone: 503 281 0561
Email: lswanstrom@aol.com


Backup Contact:

N/A


Location Contact:

Portland, Oregon 97210
United States

Lee L Swanstrom, MD
Phone: 503-281-0561
Email: lswanstrom@aol.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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